PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study

ConditionsHelicobacter Pylori Infection Post-Treatment Efficacy

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorARJ Medical, Inc.

About this trial

This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples.

Center(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System.

Treating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or Female at least 18 years of age

Patients who have been diagnosed with H. pylori and have been treated within the past 6 months

Naive to H. pylori treatment in the past 4 weeks (including PPIs)

Disqualifiers

Pregnant and/or lactating women.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Participation in other interventional trials.

Allergy to test substrates.

Trial design

Design model

Single group

Treatments tested in this trial

PyloPlus UBT System
Combination product
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Histology
Diagnostic test
Biopsy specimen fixed with 10% buffered formalin cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist.
Rapid Urease Test
Diagnostic test
Biopsy specimen obtained and placed onto Rapid Urease Test
Comparator Breath Test
Combination product
Breath will be analyzers for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
Stool Antigen Test
Diagnostic test
An antigen test performed via a laboratory to test patient's stool for H. pylori

Treatment groups

77 Participants

are divided into 1 treatment group

Group A: Indication for H. pylori testingExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

Overall Percent Agreement

The primary study endpoint is the performance measure on H. pylori eradication confirmation via PyloPlus Urea Breath Test and Comparators

Time frame

7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ARJ Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov

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